Important Safety Information

Patients should always discuss the potential risks and benefits of the Argus II Retinal Prosthesis System with a physician.

INDICATIONS FOR USE

The Argus II Retinal Prosthesis System is intended to provide electrical stimulation of the retina to induce visual perception in blind patients. It is indicated for use in patients with severe to profound retinitis pigmentosa who meet the following criteria:

Adults, age 25 years or older.

Bare light or no light perception in both eyes. (If the patient has no residual light perception, then evidence of intact inner layer retina function must be confirmed.)

Previous history of useful form vision.

Aphakic or pseudophakic. (If the patient is phakic prior to implant, the natural lens will be removed during the implant procedure.)

Patients who are willing and able to receive the recommended post-implant clinical follow-up, device fitting, and visual rehabilitation.

The Argus II implant is intended to be implanted in a single eye, typically the worse-seeing eye.

CONTRAINDICATIONS

Ocular diseases or conditions that could prevent the Argus II System from working (e.g. optic nerve disease, central retinal artery or vein occlusion, history of retinal detachment, trauma, severe strabismus, etc.).

Any disease or condition (e.g. significant cognitive decline, etc.) that prevents understanding or communication of informed consent, fitting of the Argus II System, or post-operative follow-up. A pre-operative psychological evaluation may be recommended to confirm the patient is not contraindicated based on this criterion.

Predisposition to eye rubbing.

WARNINGS

Failure to follow the recommended surgical procedure for implanting the Argus II Implant may increase the risk of adverse events and damage to the implant.

Individuals implanted with an Argus II Implant should not undergo short wave or microwave diathermy. High currents induced in the implant electrodes can cause tissue damage or serious injury. Diathermy may also cause permanent damage to the implant.

Individuals implanted with an Argus II Implant should not undergo electroconvulsive therapy (ECT) as ECT may cause tissue damage or permanent damage to the implant.

If lithotripsy or high output ultrasound must be used, do not focus the treatment beam near the Argus II Implant. Exposure of the Argus II Implant to these therapies may harm the patient or damage the implant.

The Argus II Implant has been classified as an MR Conditional device. Individuals with an Argus II Implant may undergo a magnetic resonance imaging (MRI) procedure ONLY if it is performed using a 1.5 or 3.0 Tesla MRI System and ONLY following the MRI Instructions provided later in this insert. Individuals with an Argus II Implant should not enter a room housing an MRI System that has a rating other than 1.5 or 3.0 Tesla, even if the Argus II System is not being used. The external equipment (i.e. VPU and glasses) should remain outside the MR system room, as severe harm to people in the MR system room could occur. If any pain is experienced during the MRI procedure the patient should be instructed to notify the technician immediately.

The Argus II System may interfere with the operation or accuracy of medical monitoring, diagnostic or life support equipment. Do not use the Argus II System within 3 feet of this type of equipment. If interference occurs, turn off the Argus II VPU or extend the distance between yourself and the affected equipment.

Do not use monopolar electrosurgical equipment in individuals with an Argus II Implant. Monopolar electrosurgical equipment may cause damage to the implant or to tissue surrounding the implant.

PRECAUTIONS

In the event of any undesirable sensation when using the Argus II System (for example, pain), immediately halt operation of the system by removing the Argus II Glasses or turning off the Argus II VPU.

At any time after implantation, Argus II patients have a risk of conjunctival complications which, if left untreated, may result in conjunctival erosion which could lead to endophthalmitis. Argus II recipients should be vigilant in reporting any new symptoms of foreign body sensations, tearing and/or pain promptly to their eye care professional. Long-term professional monitoring for late conjunctival issues is necessary.

The long-term effects of chronic electrical stimulation are unknown. Such effects may include deterioration of the retina or optic nerve. These effects may lead to deterioration of residual native vision and/or visual response to the Argus II System and could preclude subsequent replacement of the Argus II Implant with another retinal implant.

Individuals with an Argus II Implant should only use a VPU that has been specifically programmed for them by their clinician or Second Sight personnel. Use of a different VPU may be ineffective in providing visual information and may cause physical discomfort from overstimulation.

To avoid unsafe stimulation, do not use a VPU configured for Operating Room use for anything other than pre-implantation testing, testing during implantation, or initial fitting testing.

Individuals with an Argus II Implant should avoid physical impact or extreme direct pressure to the eye as this may result in eye trauma, movement or damage to the Argus II Implant. If this occurs, consult your physician.

Individuals with an Argus II Implant should avoid eye rubbing as this may dislodge the implant or cause eye irritation.

Individuals with an Argus II Implant should continue to use their other mobility aids (e.g. canes, dogs, etc.) at all times.

Use of the Argus II System during pregnancy and nursing has not been evaluated.

Precautions Regarding Other Medical Procedures

General Information (applicable to all procedures)

Individuals needing to undergo any of the procedures listed below, should inform his or her doctor about the existence of a retinal prosthesis in the eye. The doctor should contact Second Sight at 1-818-833-5060 for more information.

Before having any medical or test procedure that involves the use of other medical equipment, individuals with an Argus II Implant should remove the Argus II Glasses and VPU.

Once the procedure is complete, that individual should have the Argus II Implant tested as soon as possible to make sure it is still functioning properly. Damage to the implant may not be immediately detectable.

Information about Specific Procedures

Magnetic Resonance Imaging (MRI) – Refer to the Warnings section above and the MRI Information section below for more information about MRI.

The use of laser, phacoemulsification, or fragmatome may damage the Argus II Implant. If these procedures must be used in an implanted eye, do not direct the laser beam at the implant. Extra caution should be used when performing these procedures intraocularly as visualization of the implant may be obscured.

The use of bipolar electrosurgical equipment may damage the Argus II Implant. Use caution when using this equipment near the implant.

CT Scans or Diagnostic Ultrasound may be performed in individuals with an Argus II Implant. However, if a scan or ultrasound is performed in the region where the Argus II Implant is located, the implant may create an image artifact making the scan unreadable in this region.

Use of defibrillators or therapeutic ionizing radiation to the head may permanently damage the Argus II Implant. However, this should not preclude or change the way in which these treatments are delivered. The Argus II Implant should be tested by a qualified clinician or Second Sight personnel as soon as possible following the procedure or defibrillator activation to confirm that it is still functioning properly. Damage to the implant may not be immediately detectable.

The effects of cobalt treatment and linear acceleration techniques on the implant are unknown.

Electromagnetic Interference (EMI)

Electromagnetic interference is a field of energy (electrical, magnetic, or both) created by equipment found in public environments that may be strong enough to interfere with the normal operation of the Argus II System. The Argus II System meets international standards for electromagnetic compatibility and is designed to continue to operate in a “safe mode” in the presence of any electromagnetic interference which would normally be encountered during every day use of the Argus II System. It is important to note, however, that in certain circumstances, electromagnetic interference could cause the following:

Serious injury. Exposure of the implant to EMI may result in the implant heating and damaging nearby retinal tissue. See “Warnings” .

Damage to the Argus II implant. Damage to the implant may require replacement, or result in loss of, or irreversible change in the performance of the Argus II System. See “Warnings” .

Unexpected Turning off of the Argus II VPU. EMI may cause the VPU to turn off unexpectedly.

Interruption of Stimulation. EMI may cause a momentary interruption of stimulation.

Argus II System users should be advised that upon entering an environment which maybe causing interference with the Argus II System, they should move away from the equipment or object thought to be causing the interference, if possible, turn off the equipment or object causing the interference, tell the equipment operator or the doctor what happened and, if they continue to experience interference or think that the Argus II System is not working as well as it did before they encountered the interference, to contact their doctor.

Possible Interference with Other Electronic Devices

Theft or metal detectors (such as those located in entrances to public buildings and department stores) and airport or security screeningdevices may temporarily interrupt Argus II stimulation if the Argus II System is used within 1 yard (0.9 meters) of them. Normal operation will resume when you move away from these items. When possible, it is best to avoid these devices or turn the VPU off when passing through these systems. Individuals with an Argus II Implant should show their ID card to any attendant in the area who may be able to assist them in bypassing the devices. If unavoidable, walk through the scanner and promptly move away from the area. Do not lean on these scanners or linger in their path.

Electronic Article Surveillance (EAS) systems, EAS Tag Deactivators, and Radiofrequency identification (RFID) systems may temporarily interrupt Argus II stimulation if the Argus II System is used within 3.5 yards (3.2 meters) of them. Normal operation will resume when you move away from these items. RFID systems and EAS systems and tag deactivators send out energy fields that wirelessly communicate with tags that are attached to objects such as merchandise, materials and people. These systems are used for security, theft prevention, tracking and inventory control and they are usually found in retail stores, libraries, government buildings, warehouses and offices. For example, security tags attached to clothing contain RFID tags.

Electrostatic Discharge (ESD) may interfere with normal operation or cause damage to the electrical components of the Argus II System. Common situations that create static electricity include putting on or removing clothes, or dragging feet across a carpet or rug when there is less than 30% relative humidity. Care should be taken to avoid handling the VPU and glasses when static electricity is present.

The Argus II System may interfere with the normal operation of some models of hearing aids. Hearing aids should be tested prior to implantation, to ensure proper functioning of both the Argus II System and the hearing device.

Some home appliances (for example, microwaves) and some devices with antennae (for example, cell phones, and cordless phones) may temporarily interrupt Argus II stimulation if the Argus II System is being used near them.

The Argus II System operates using wireless technology which could interfere with the safe operation of an airplane. Patients should not turn on the Argus II System on an airplane.

Air Travel, General Travel and International Use

CAUTION: The Argus II System operates using wireless technologies that could interfere with the safe operation of an airplane and should not be turned on or used on an airplane.

When travelling and not using the Argus II System, individuals should be advised to store the external equipment in the travel case. International travel may require the use of adapters to be able to plug the VPU battery charger into an electrical outlet. Individuals with the Argus II System should be advised to both bring their patient identification card with them to assist in going through security systems and to turn off the VPU. If individuals with the Argus II System are experiencing any medical complications before traveling, they should be advised to speak with a doctor to determine if it is safe for them to travel, especially on a plane. They also may wish to obtain the name of a local ophthalmologist, in the event of any complications during their travels.

Precautions in the Event of Change in Device Performance

If there is a notable change in performance with the Argus II System, the patient should contact his or her clinician for assistance. A visit to the clinic for troubleshooting, diagnostic tests, or re-programming may be required.

ADVERSE EVENTS

Adverse events related to the device, therapy or surgical procedure can include:

HUMANITARIAN DEVICE: Authorized by Federal (U.S.) law to provide electrical stimulation of the retina to induce visual perception in blind patients with severe to profound retinitis pigmentosa and bare light or no light perception in both eyes. The effectiveness of this device for this use has not been demonstrated.

Rx Only: Federal law restricts this device to sale by or on the order of a physician.